Imaging Beta-amyloid in Middle Age Alcoholics As a Mechanism That Increases Their Risk for Alzheimer's Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- [C-11]PIB +
研究概览
简要总结
To determine whether alcoholics (AUD) have a greater rate of amyloid positivity (ABeta+) compared to an age-matched cognitively normal control group (HC).
详细描述
There is a long-established relationship between alcohol use disorders (AUD), cognitive impairments, and the development of dementia. Some, but not all basic data suggest that alcohol abuse can alter the expression of amyloid precursor protein, and the enzymes that process it. Thus, there is a need for in vivo PET studies to further investigate the relationship between AUD and AD and the mechanism through which alcohol abuse exerts its effect on this type of dementia. Here, we propose to use the amyloid Beta (ABeta) radiotracer carbon-11 labeled Pittsburgh Compound-B ([C-11]PiB) and PET (Klunk et al., 2004) to determine whether AUD increase the risk to be brain ABeta+ in middle aged adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females between 40 and 65 years old
- •Fulfill DSM-5 criteria for alcohol use disorder of at least moderate severity
- •Current heavy drinking as defined in SAMHSA criteria (i.e., drinking 5 or more drinks on the same occasion on each of 5 or more days in the past 30 days)
排除标准
- •DSM-5 schizophrenia, schizoaffective disorder, bipolar disorder (SCID-5) and prior history of developmental disorders, such as Autism, Down's Syndrome, Intellectual disability.
- •A positive urine drug screen at screening for amphetamines, cocaine, methamphetamine, opioids, barbituates and PCP
- •History of severe unstable medical or neurological illnesses that could affect neuropsychological testing
- •History of cancer (other than skin or in situ prostate cancer) within the previous 5 years
- •Currently pregnant or breastfeeding
- •Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
- •Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
- •No first-degree relative with Alzheimer's disease or related dementias
- •(B) Healthy Control Subjects (HC)
- •Inclusion Criteria:
- •(1) Males or females between 40 and 65 years old
- •Exclusion criteria:
- •Current or past DSM-5 psychiatric and/or addictive disorders
- •Current heavy drinking as defined in SAMHSA criteria
- •History of severe unstable medical or neurological illnesses that could affect neuropsychological testing
- •History of cancer (other than skin or in situ prostate cancer) within the previous 5 years
- •Currently pregnant or breastfeeding
- •Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
- •Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
- •No first-degree relative with Alzheimer's disease or related dementias
研究组 & 干预措施
Alcohol use disorders
[C-11]Pittsburgh Compound B (PiB) PET scan
干预措施: [C-11] (Radiation)
Alcohol use disorders
[C-11]Pittsburgh Compound B (PiB) PET scan
干预措施: Pittsburgh Compound B (Drug)
Healthy controls
[C-11]Pittsburgh Compound B (PiB) PET scan
干预措施: [C-11] (Radiation)
Healthy controls
[C-11]Pittsburgh Compound B (PiB) PET scan
干预措施: Pittsburgh Compound B (Drug)
结局指标
主要结局
[C-11]PIB +
时间窗: Baseline
positive/negative
次要结局
未报告次要终点
研究者
Rajesh Narendran
Professor of Radiology and Psychiatry
University of Pittsburgh